Disinfectants Cleared for Reusable Devices

The FDA Approves 17 Sterilizing and Disinfecting Products for Reprocessing Medical Devices

The Food and Drug Administration (FDA) released a list of the latest approved disinfectants for reprocessing medical devices as of January 28, 2000. The following company products were approved through the 510(k) process:

Advanced Sterilization Products:

- Cidex OPA Solution High Level Disinfectant, (0.55% ortho-phthaldehyde), K991487

Sporicidin International:

- Sporicidin Sterilizing and Disinfecting Solution (0.95% glut and 1.64% phenol/phenate), K983194

Johnson & Johnson Medical Products, Inc.

- Cidex Activated Dialdehyde Solution (2.4% glut), K924434

- Cidex Formula 7 Long-Life Activated Dialdehyde Solution (2.5% glut), K924334

- Cidex Plus 28 Day Solution (3.4% glut), K923744

Metrex Research, Inc.:

- Metricide Activated Dialdehyde Solution (2.6% glut), K930284

- Metricide Plus 30 Long-Life Activated Dialdehyde Solution (3.4% glut), K931592

- Metricide 28 Day Long-Life Activated Dialdehyde Solution (2.5% glut), K931052

Cottrell Limited:

- Procide 14 N.S. (2.4% glut), K932922

- Omnicide Long-Life Activated Dialdehyde Solution (2.4% glut), K932922

- Omnicide Plus (3.4% glut), K932922

Wave Energy Systems:

- Wavicide --01 (2.5% glut), K914749

STERIS Corporation:

- STERIS 20 Sterilant (0.2% peracetic acid), K875280

Minntech Corporation:

- Peract 20 Liquid Sterilant/Disinfectant (0.08% peroxyacetic acid and 1.0% hydrogen peroxide), K960513

Reckitt & Colman, Inc.:

- Sporox Sterilizing & Disinfection Solution (7.5% hydrogen peroxide), K970230

MedSci, Inc.:

- MedSci 3% Glutaraldehyde (3% glut), K974062

Cetylite Industries, Inc.:

- Cetylcide-G Concentrate and Diluent Concentrate (3.2% glut), K974188

More information can be obtained on the Internet at http://www.fda.gov/cdrh/ode/germlab.html.

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